Senior Supplier Quality Engineer (Medical Devices)

TL;DR

Senior Supplier Quality Engineer (Medical Devices): Lead supplier quality deliverables and control activities for new product development programs within the Aortic portfolio with an accent on component development, qualification, and regulatory compliance. Focus on managing supplier changes during NPD, resolving technical issues using structured problem-solving, and ensuring seamless program execution.

Location: Must be based in Brooklyn Park, MN, USA (onsite minimum 4 days per week)

Salary: $99,200 - $148,800 USD

Company

Global leader in healthcare technology focused on alleviating pain, restoring health, and extending life through innovative medical solutions.

What you will do

• Provide technical guidance and quality compliance for Supplier Quality throughout the NPD lifecycle for newly qualified parts.
• Drive supplier qualification activities, including process development reviews, capability assessments, and readiness evaluations.
• Lead and approve component qualification activities to ensure alignment with corporate quality standards.
• Manage supplier changes during NPD and early commercialization, assessing impacts on risk profiles and validations.
• Partner with R&D, Manufacturing Engineering, and Regulatory teams to ensure components meet design intent and manufacturability.
• Lead supplier issue resolution using structured problem-solving methodologies and implement corrective and preventive actions.

Requirements

• Baccalaureate degree with 4+ years of relevant experience, Master's with 2+ years, or PhD.
• Unrestricted U.S. work authorization is required (sponsorship not available for this level).
• Location: Must be able to work onsite in Brooklyn Park, MN at least 4 days per week.
• Experience in supplier control and quality deliverables for new product development.

Nice to have

• Engineering experience with disposable medical devices or capital equipment.
• Working knowledge of Production Part Approval Process (PPAP).
• Basic understanding of cardiovascular device applications and heart anatomy.
• Experience supporting cross-functional teams in a matrixed organization.

Culture & Benefits

• Comprehensive health, dental, and vision insurance, including HSA and Healthcare FSA.
• 401(k) plan with employer contribution and matching.
• Paid time off, paid holidays, and short-term disability leave.
• Tuition assistance/reimbursement and the Simple Steps global well-being program.
• Employee Stock Purchase Plan and other retirement supplements.